Type 2 diabetes
Conditions
Interventions
Orally administration of 50 mg ipragliflozin once a day, pre or post breakfast for 52 weeks
Sponsors
Seino Naika Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Aged from 20 to 80 years at providing consent 2) With poorly controlled patients who undergoes diet/exercise therapy or hypoglycemic agent at least 12 weeks 3) HbA1c >= 6.5 and < 9.5% 4) BMI >= 20kg/m2 5) Provide written informed consent
Exclusion criteria
Exclusion criteria: 1) Type 1 diabetes 2) With severe ketosis, diabetic coma, or precoma within 6 months 3) With severe infection, pre or post surgery, and serious trauma 4) With moderate or severe renal dysfunction (Serum Creatinine male: >= 1.5mg/dL, female: >= 1.3mg/dL) 5) Has stroke, myocardial infarction, or other serious cardiovascular complications requireing hospitalization within 6 months 6) Is receiving SGLT-2 inhibitor at initiation 7) Is nursing or pregnant or planned to become pregnant 8) Has hypersensitivity to ipragliflozin or any other excipient of ipragliflozin 9) Considered as inadequate by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change and percent change in HbA1c from baseline to 52 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Change and percent change in following items from baseline to 12, 24, and 52 weeks 1) HbA1c (Except for the change at 52 week) 2) fasting plasma glucose, insulin, HOMA-beta, HOMA-R 3) body weight and waist circumference 4) Serum lipid (TC, LDL-C, TG, HLD-C) 5) Blood pressure | — |
Countries
Japan
Contacts
Public ContactHiroaki Seino
Seino Naika Clinic Medical director
Outcome results
None listed